P2a Open Label Study to Evaluate 2-HPβCD in Subjects With Diabetic Kidney Disease
brief summary
This is an open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) given intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria.
detailed description
This is a Phase 2a, open label, two to three center study to evaluate the clinical efficacy and safety of 1 dose level of 2-hydroxypropyl-β-cyclodextrin (2-HPβCD) given intravenously in adult patients with type 2 diabetes with diabetic kidney disease (DKD) and proteinuria.
The study will be conducted at 2 - 3 sites in the United States of America (USA) and will screen a sufficient number of subjects to complete 8 participants meeting the inclusion/exclusion criteria outlined.
The study consists of up to a 4-week screening period, a 12-week treatment period and a 4-week follow-up period.
official title
A Phase 2a Open Label Study to Evaluate Cholesterol Efflux Mediator™ VAR200: 2- Hydroxypropyl-β-cyclodextrin (2-HPβCD) in Subjects With Type 2 Diabetic Kidney Disease (DKD)